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Ultrasound zaps brain barrier in Parkinson's dementia – first safety results in

NCT ID NCT03608553

Knowledge-focused Sponsor: InSightec Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a focused ultrasound device can safely and temporarily open the blood-brain barrier in 20 people with mild-to-moderate Parkinson's disease dementia. The goal was to see if the procedure is safe and feasible, not to treat the disease itself. Researchers monitored side effects using exams and brain scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MR-guided focused ultrasound (Exablate device)
What this could lead to
If successful, this approach could enable future treatments to reach the brain more effectively for Parkinson's dementia.
What could go wrong
This was a very small, early feasibility study with only 20 participants. It focused on safety, not on treating symptoms or slowing the disease. The procedure may carry risks like bleeding or swelling in the brain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Nov 2018

Finished

Aug 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Primary Inclusion Criteria: 1. Parkinson´s Disease, according to the UK Parkinson´s Disease Society Brain Bank (Gelb et al. 1999) 2. Parkinson´s Disease patients diagnosed with mild-moderate dementia according to the Movement Disorders Criteria (Emre et al. 2007) 3. Able and willing to give informed consent, or has delegated this to a substitute decision maker. 4. Mini Mental State Exam (MMSE) scores ≥16 (able to complete a Neuropsychological evaluation) 5. Geriatric Depression Scale (GDS) score of ≤ 20 6. Age: 60-80 years 7. Able to attend all study visits (i.e., life expectancy of 1 year). Primary Exclusion Criteria: 1. Clips or other metallic implanted objects in the skull or the brain, except shunts 2. Significant cardiac disease or unstable hemodynamic status 3. Uncontrolled hypertension (systolic \> 150 and diastolic BP \> 100 on medication) 4. Medications known to increase risk of hemorrhage, (e.g.: patients should be off of ASA for at least 7 days prior to treatment) or anticoagulants 5. History of a bleeding disorder 6. Significant depression and at potential risk of suicide 7. Known sensitivity/allergy to gadolinium 8. Any contraindications to MRI scanning 9. History of seizure disorder or epilepsy 10. History of drug or alcohol use disorder who may be at higher risk for seizure, infection, or poor executive functioning 11. Chronic breathing disorders

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Conditions

The condition(s) this trial relates to.

Lewy body dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinsons disease with dementia

Contacts and locations

Locations

  • HM Hospitales Puerta del Sur - CINAC

    Móstoles, Madrid, 28938, Spain

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